BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19517281 · Received June 12, 2024

    Report

    Report Number
    2955842-2024-15326
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 16, 2024
    Report Date
    May 16, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) ASSOCIATED WITH THE CUSTOMER-REPORTED COMPLAINT. THE UNIT WAS ANALYZED, AND THE REPORTED PROBLEM WAS CONFIRMED. IT WAS CONFIRMED VIA ERROR LOGS AS HAVING OCCURRED IN THE FIELD. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND PASSED IN NORMAL MODE. THE UNIT WAS ALSO TESTED ON A TESTING PLATFORM, AND THE FIBER TEST FAILED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. DURING FIELD EVALUATION, FSE CONFIRMED A FAULTY USM ARM. AFTER REPLACEMENT, THE DA VINCI SYSTEM WAS RECALIBRATED, TESTED, OPERATED WITHOUT ERROR AND VERIFIED READY FOR USE. INTUITIVE SURGICAL INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT ASSOCIATED WITH THE CUSTOMER-REPORTED COMPLAINT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, RECOVERABLE FAULTS ON UNIVERSAL SURGICAL MANIPULATOR (USM)2 WAS OBSERVED. ISI TECHNICAL SUPPORT ENGINEER (TSE) CHECKED SYSTEM LOGS AND FOUND ERRORS 31226, 23098,32114,40084,40100 AND 40106 ON USM2. TSE ASKED THE CALLER TO TRY TO RECOVER THE FAULTS, TRY A HARD POWER CYCLE OF THE SYSTEM EMERGENCY POWER OFF (EPO) BUT ISSUE PERSISTED. TSE THEN ASKED TO CALLER IF IT WAS POSSIBLE TO PROCEED WITH THE SURGERY WITHOUT USM2. CALLER CONFIRMED. TSE SUPPORTED THE CUSTOMER TO DISABLE THE USM2. THE PROCEDURE WAS CONTINUED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394378 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-37 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES